The following data is part of a premarket notification filed by Alicn Medical Shenzhen,inc with the FDA for Arm Blood Pressure Monitor.
| Device ID | K221913 |
| 510k Number | K221913 |
| Device Name: | Arm Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Street Shenzhen, CN 518118 |
| Contact | Fang Meisong |
| Correspondent | Fang Meisong Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Street Shenzhen, CN 518118 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-30 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06953775621915 | K221913 | 000 |
| 06953775660112 | K221913 | 000 |
| 06953775609203 | K221913 | 000 |